Tracking surgical implements with integrated circuits

ABSTRACT

A system and method of tracking medical products provides for associating a group of medical products with a group location based on a group radio frequency identification (RF ID) device signal, where the group includes a first unit a second unit. The first unit is associated with a first remote location based on a first unit RE ID device signal. The method further provides for associating the second unit with a second remote location based on a second unit RE ID device signal. The signals uniquely identify the units and the group.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of prior application U.S. Ser. No.10/106,183 filed Mar. 27, 2002 and issued as U.S. Pat. No. 6,861,954,which is a continuation-in-part application of abandoned U.S. Ser. No.09/883,991 filed Jun. 20, 2001, which claims the benefit of U.S.provisional application No. 60/280,206 filed Mar. 30, 2001.

FIELD OF THE INVENTION

The present invention relates to devices, labels, methods, and systemsto monitor and track medical implements and products containingintegrated circuits. Specifically, embodiments of the present inventionrelate to preventing these medical implements from being inadvertentlyleft within a human or animal following completion of medicalprocedures. In addition, embodiments of the present invention are meantto decrease errors resulting from sub-optimal production, processing,distribution, and administration of medical products, including but notlimited to pharmaceuticals and blood products. Embodiments of thepresent invention also pertain to managing medical products, medicaldevices and disposables, such as medications, blood, and tissueproducts, and more particularly to the use of electronic means such asradio frequency identification (RF ID) devices to assist in themanagement process from point of origin to end use.

BACKGROUND OF THE INVENTION

During surgery it is necessary to place surgical implements, such assponges, scalpels, needles, gauzes, and the like near or into a woundcavity. Even though thorough manual counts are conducted following thecompletion of surgery, this method is time consuming, tedious and errorprone. Indeed, surgical implements are too frequently left insidepatients resulting in complications including trauma, pain, infection ordeath.

A number of conventional methods exist to make sure that all surgicalimplements have been removed from a patient, but all have drawbacks. Themost well known method is to use X-rays. In this procedure, the surgicalimplements have radio opaque material embedded within them. Followingthe completion of surgery and suturing of the patient, an X-ray machineis moved over the patient and an X-ray is taken of the wound area todetermine whether radio opaque materials are present in the patient.However, some materials may be too small to be easily seen on X-ray, orthey may be otherwise obscured by bone or tissues within radio denseareas. If any surgical implements are found on the X-ray within thesutured area, then the patient is reopened to retrieve the retainedmaterials. This way, implements left within a patient are removed.However, each time this procedure is performed, expensive operating roomtime is wasted and other patients may have their surgeries delayed.Furthermore, the patient is subjected to more anesthesia time andotherwise unnecessary radiation.

Another method suggested by U.S. Pat. No. 4,193,405 to Abels, detects aradio-frequency (“RF”) transponder embedded in a surgical sponge. Inthis method, tagging of surgical articles with ferrite or othersemiconductor material is done such that when they are exposed to twoselected frequencies the material will resonate. This resonance can thenbe detected by a RF receiver. However, this method merely relates to atransponder, no data is recorded as to type of object, time rank ofobject, nor does it allow for master categorization which would alertthe user that an object is in fact missing, even in the absence of adetected failure. Hence, this level of safety is easily breached.

In U.S. Pat. No. 4,658,818 to Miller, a miniature battery-poweredoscillator is attached to each surgical implement and activated prior toits initial use. The output of each oscillator is in the form of a lowpowered pulse which is coupled to the body's fluids and tissue. Afterthe surgery is completed, but prior to suturing, a detection system isused to sense for any pulses generated within the body. However, thissystem also does not provide information as to object type, rank timingor master categorization, and merely serves as a pulse alarm.

Another system that has recently been devised is disclosed in U.S. Pat.No. 5,931,824 to Stewart. This system is drawn to placingmachine-readable information on individual surgical sponges. Inaddition, each sponge has X-ray detectable material embedded within it.This system requires that each sponge is scanned which is tedious, andallows for neither non-orientational registration nor perimeterscanning.

Additionally, sub-optimal logistics result in medication and othererrors, which have resulted in significant morbidity and mortality.

Furthermore, tracking and distributing medications and blood or tissueproducts from their points of origin to their appropriate administrationto patients requires a very major commitment of dedicated resources tomaintain acceptable safety and efficiency. Unfortunately, commonlyutilized methodologies can be expensive, wasteful, and potentiallyhazardous as they rely heavily on human input and require sustainablelevels of efficiency that may be unrealistically high. As any breach ofvigilance resulting from suboptimal visual or other input, stress,fatigue, repetition or distraction can have dire consequences atmultiple points, risk exposure is significant. Medications may be poorlytracked leading to shortages in inventory or inappropriate use ofoutdated medications. Inappropriate formulations or concentrations ofdrug may be found in improper locations in the hospital, clinic or otherpatient care facility and this can result in improper dosing.

Furthermore, allergies or other adverse medication reactions, as well ashazardous drug interactions may go unrecognized or ineffectivelyaddressed by patient care providers or other ancillary medical staff.Blood product preparation is an expensive and complex endeavor andcurrent procedures for tracking blood products at the point ofcollection through the point of distribution can be suboptimal.Additionally, the procedures can be subject to hazard as human error atseveral points can lead to fatalities. For example, one concern is thepotential for busy clinicians to misread one or more of a series ofnumbers and letters on a patient ID bracelet or unit of packed red bloodcells during a severe bleeding episode in an operating room. Hence,there is a need for effective and safe methodologies for trackingmedications and blood and other tissue products from the point ofproduction to the point of administration.

A number of tracking devices have been well documented. For example,U.S. Pat. No. 6,130,613 shows a radio frequency identification stamp(10) having a substrate (24) with a first surface (12) and a secondsurface (18). The first surface (12) is printed with indicia indicatingat least a postage value. An antenna (16) is formed on the secondsurface (18) and a radio frequency identification circuit chip (20) issecured to the second surface (18) and coupled to the antenna (16). Alayer (22) of adhesive is also disposed on the second surface (18). Amailing label (600) includes indicia (614) printed on a first surface,and an antenna (616) coupled to a radio frequency identification circuitchip (620) on a second surface (618). A layer (622) of adhesive coversthe second surface. The layer bonds the circuit chip (620) to the secondsurface and couples the circuit chip (620) to the antenna (616). Thecircuit chip (620) may retain a tracking number, and more preferably,retains sender information (601), recipient information (602), servicetype information (603) and billing instructions (604).

SUMMARY OF THE INVENTION

The present invention provides devices, methods, and systems thatmonitor and track medical materials, including surgical implements.

In an embodiment of the present invention, a surgical implementincluding at least one integrated circuit that uniquely identifies thesurgical implement by a unique identifier is provided.

In another embodiment of the present invention, a method for monitoringand tracking surgical implements is provided. The method includesidentifying at least one surgical implement including an integratedchip, where each surgical implement is uniquely identified. Anothermethod of the present invention provides for monitoring and trackingmedical materials. This method includes uniquely identifying at leastone medical material by a unique identifier, each medical materialincluding at least one integrated circuit having the unique identifierprogrammed therein and monitoring each medical material by its uniqueidentifier. In another embodiment of the present invention, a method formonitoring surgical implements in conjunction with a surgical procedureis provided. The method includes initializing at least one surgicalimplement where each surgical implement includes an integrated circuit,registering the surgical implement prior to a surgical procedure byprogramming a unique identifier in the integrated circuit, andaccounting for the surgical implement at the completion of the surgicalprocedure by receiving the unique identifier from the surgicalinstrument.

The present invention also includes systems. In one embodiment of thepresent invention a system for monitoring and tracking surgicalimplements is provided. The system includes at least one surgicalimplement, each surgical implement including an integrated circuit thatstores a unique identifier of the surgical instrument and a detectorthat detects the surgical implement by detecting the unique identifierfrom the integrated circuit. Another embodiment of the present inventionincludes a system for monitoring and tracking surgical implementsincluding at least one surgical implements, including at least oneintegrated circuit and a sensor for sensing the surgical implementsbased on a signal received from each integrated circuit. In anotherembodiment of the present invention, a system for monitoring surgicalimplements used in conjunction with a surgical procedure is provided.This system includes at least one surgical implement comprising anintegrated circuit, the integrated circuit associating a uniqueidentifier with each of the surgical implements and emitting a signalcontaining the unique identifier, a detector that detects the signalemitted by the surgical implement, and an output device to processinformation provided by the detector. The present invention alsoprovides another embodiment of a system, including at least one surgicalimplement comprising an integrated circuit, the integrated circuitassociating a unique identifier with each of the surgical implements andemitting a signal containing the unique identifier, a platform with adetector that detects the signal and determines a placement and removalof each of the surgical implements from the platform based on thedetected signal, and an output device that receives and processesinformation provided by the detector. Another embodiment of the presentinvention provides a system for monitoring patients including at leastone medical material, each medical material including a first integratedcircuit, at least one patient identification tag, each patientidentification tag including a second integrated circuit, and a sensorthat monitors the medical materials and patient identification tagsbased on signals received from the first and second integrated circuits.

The present invention also provides a medical label including at leastone integrated circuit, where the integrated circuit uniquely identifiesa medical product the medical label is attached to. In anotherembodiment of the present invention, a blood product label is provided,which includes a label attached to a blood product, the label includingat least one integrated circuit that uniquely identifies the bloodproduct. The present invention also provides a blood product containerincluding the blood product label. Finally, the present inventionprovides medical product including at least one integrated circuit thatuniquely identifies the medical product by a unique identifier

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a block diagram of the sensor system and two integratedcircuits to be used in surgical implements.

FIG. 2 shows a block diagram of the sensor system and two integratedcircuits to be used in surgical implements.

FIG. 3 shows an embodiment of a database table for the sensor system.

FIG. 4 shows an embodiment of a database table for the sensor system.

FIG. 5 shows a flow chart of registration instructions for the sensorsystem.

FIG. 6 shows an embodiment of the sensor system in a patient ID braceletand integrated circuits in blood bags and syringes.

FIG. 7 shows a diagram of an example of a medical product infrastructureutilizing an assembly of medical products in accordance with oneembodiment of the invention.

FIG. 8 shows a diagram of an example of a health care facility utilizingan assembly of medical products in accordance with one embodiment.

FIG. 9 shows a flow chart of an example of a method of tracking medicalproducts in accordance with one embodiment of the invention.

DETAILED DESCRIPTION

Embodiments of the present invention relate to methods, devices, labels,and systems for monitoring medical implements products containingintegrated circuits, microchips, or Radio Frequency Ids (RFID). Prior toa medical procedure, each of the implements to be used is registeredwith a sensor system such that the implement is uniquely identified.Following the medical procedure, each of the implements that wasregistered is then accounted for.

FIG. 1 shows an example of one embodiment of the present invention. Likeelements are labeled with like numbers. In FIG. 1, two surgicalimplements 10 and 11 are shown and a sensor system 100. Surgicalimplements, as used herein, include, but are not limited to, sponges,needles, scalpels, gauze, forceps, and scissors and the like.

Also, the scope of the term surgery or surgical is not to be limited,but should include all types of medical procedures and is used hereininterchangeably with the term medical.

In FIG. 1, surgical implement 10 includes an integrated circuit 20, andsurgical implement 11 includes an integrated circuit 21. The integratedcircuit 20 includes an analog front-end 50, which could, for example, bea LC circuit; a memory 40; and a controller 30. In the memory 40 ofsurgical implement 20 there can be stored a programmable surgicalimplement identifier 65. This programmable surgical implement identifieris used as a unique identifier for each surgical implement. Thisparticular illustration is but one example of how the present inventioncould be practiced and is not meant to limit the scope in any way.

The integrated circuits 20 and 21 are powered through radio frequency(“RF”) signals generated by the sensor system 100. However, theintegrated circuits may also be powered by any known source of energy,including, but not limited to, a battery, exposure to air, moisture,certain chemicals or substances, changes in temperature, pH, or motion.Additionally, the integrated circuits may be powered by induction, EMF,other radiation or by the potential, chemical, or electrical gradients,or micro-electric currents of the body.

The integrated circuits 20 and 21 are encapsulated in plastic and thenincorporated into surgical implements. Generally, the integratedcircuits are incorporated into each of the different surgical implementsor materials natively. Therefore the integrated circuits areincorporated in such a way as to be encapsulated, hermetically sealed,flexible, heat, shock and water resistant and sterilized orsterilizable. The integrated circuits are also incorporated in a mannerthat does not impede or hinder the normal function of the medicalimplement. Because the surgical implements include many differentinstruments, incorporation of the integrated circuits into eachdifferent implement needs to be individualized to that implement andthis can be done by those of skill in the art. Also, the integratedcircuits can be incorporated into or structurally associated with x-rayopaque material.

FIG. 1 also shows a sensor system 100. The sensor system 100 includes aprocessor 120, a memory 130, and a transmitter 110. The memory 130 ofthe sensor system includes registration instructions 135 andregistration data 140. The processor 120 can be a Pentium® IIImanufactured by Intel of Santa Clara, Calif., an Application Specificintegrated circuit (“ASIC”), a microcontroller, etc. The registrationinstructions 135 will be explained more fully with reference to FIG. 5and the registration data 140 will be explained more fully withreference to FIG. 3 and FIG. 4. The sensor system 100 may also includean interface consisting of a computer terminal or terminals (not shown).In addition, there may be additional auxiliary sensory systems used inconjunction with the main sensor system throughout an operating room.Operating room as used herein, includes, but is not limited to, anoperating theater, an operating room, an operating suite, or any otherroom where surgery or any invasive procedure of any type is performed onhumans or animals.

One example of an integrated circuit and corresponding base station thata person of ordinary skill in the art could use to practice the presentinvention is TEMIC Semiconductors TK5552 transponder integrated circuitand base station, as described in TEMIC Semiconductors, “TK5552”, Rev.A4, 26 Apr. 2000, which is hereby incorporated by reference, in itsentirety. TEMIC Semiconductors' TK5552 integrated circuit transponder isa programmable read/write transponder with an operation range of up to10 cm powered by a RF field generated by the base station.

Other embodiments of the integrated circuit can be made of molecularswitches using nanotubes as wires, such as described by Rotman in“Molecular Computing” Technology Review 103: 52-58 (May-June 2000), ormolecular conductors such as benzine dithol as described by Reed et al.in “Computing with Molecules” Scientific American, 282: (June 2000),both of which are hereby incorporated by reference in their entirety.

In addition, the integrated circuit can be a RFID. The RFID may bereadable only or readable and writeable. One example of an RFID thatcould be used in the present invention is disclosed in U.S. Pat. No.6,249,227, hereby incorporated by reference, in its entirety.

Embodiments of the present invention relate to tracking and monitoringsurgical implements. To that end, as can be seen in FIG. 1, data is readand written to and from the sensor system 100 and integrated circuits 20and 21. The sensor system 100 assigns the programmable surgicalimplement identifier 60 to the surgical implement 10 and surgicalimplement identifier 61 to surgical implement 11 while collectingvarious % data to compile the registration data 140 in the sensor system100 and memory 130.

An example set of registration instructions 135 stored in the memory 130of the sensor system 100 is shown in FIG. 5. In the first step 200, thesensor system 100 scans a first surgical implement and receives thesurgical implement identifier of the first surgical implement. At step210, the surgical implement identifier of the first surgical implementis stored in the registration data 140 in the memory 130 of the sensorsystem 100 in a first data record. In step 220 the sensor system 100scans a second surgical implement and receives a surgical implementidentifier of the second surgical implement. At step 230 the surgicalimplement identifier of the second surgical implement is stored in asecond data record in the registration data 140. In step 240 the sensorsystem 100 re-scans the first surgical implement and re-receives thesurgical implement identifier of the first surgical implement. In step250 the first data record is updated based at least in part on there-received surgical implement identifier of the first surgicalimplement.

The registration data 140 can be a relational database 170 shown in FIG.3. Database 170 includes records 184-190, which are accessible using asuitable database management system software. Each record 184-190 ofdatabase 170 contains six fields 172-182. Field 172 holds the surgicalimplement identifier, which can be any unique identifier, for example anumber(s), letter(s), a combination of numbers and letters, a frequency,or the like. In this embodiment, the memory 40 of the integrated circuit20 is programmable, so the surgical implement identifier 60 isprogrammable. Therefore, field 172 can be programed by the sensorsystem. Field 174 indicates the initial time of registration, forexample when the sensor system first senses the surgical implement andis associated with a registration identifier. Field 176 indicates whenthe given surgical implement was checked out to be used in a surgery andis associated with a checked-out identifier. Field 178 holds informationabout when the given surgical implement was checked back in following ituse and is associated with a checked-in identifier. Field 180 holdsinformation about the check-in location within the operating room andfield 182 indicates what the actual surgical implement is, for example,a sponge, a scalpel, gauze, or the like. This particular arrangement offields is but one illustration of how the invention may be practiced.For example, certain fields can be omitted, additional fields can beprovided, or the arrangement of fields can be changed. For example,additional fields for the check-in or check-out location can be added.Also, a field could be added that indicated the count of each implement.For example, that a particular sponge was sponge five of twenty—5/20 orthat a scalpel was two of five—2/5.

Each record 184-190 of database 170 associates a surgical implementidentifier with time of check-out and time of check-in. In addition,other information is associated with each surgical implement, forexample, the actual surgical implement and the location of its check-in.By compiling this information it becomes possible to monitor eachindividual surgical implement.

FIG. 2 shows a similar embodiment as FIG. 1, except that the data isonly shown being read by the sensor system 100. The memory 40 of theintegrated circuit 22 has a pre-programmed surgical implement identifier65 as compared to the programmable surgical implement identifier 60 ofFIG. 1, and integrated circuit 23 has a pre-programmed surgicalimplement identifier 66.

FIG. 4 shows database 150, which could be used with the embodiment ofthe present invention shown in FIG. 2. Database 150 includes records160-166, which are accessible using a suitable database managementsystem software. Each record 160-166 of database 150 contains threefields 152-156. Field 152 contains the surgical implement identifier,which is pre-programed in the surgical implement. The pre-programedidentifier could be programed, for example, in such a way as to indicatethe hospital, the type of implement, the number of the implement, orother parameters desired to be associated with the implement. Thisparticular programing is one illustration of how the invention may bepracticed. Field 154 corresponds to a check-in “flag” if the surgicalimplement has been taken to be used, while field 156 corresponds to acheck-out “flag” when the surgical implement is brought back after beingused. This is a simplified version of the database shown in FIG. 3.

Prior to surgery, each surgical implement having an integrated circuitin it is placed on or near the main sensor system. The sensor systemassigns an individual surgical implement identifier to each surgicalimplement and records initial data (e.g., initial time of registration).In order to make sure that no unregistered implements are located withinthe operating room, the sensor system will note all incomplete implementintegrated circuit data profiles and alert upon such sensing. When thesurgery begins and the surgical implements are used, the sensor systemrecords the time each surgical implement is checked-out/used. When thesurgical implement is done being used and the surgical implement isreplaced either on or near the main sensor system or in an auxiliarysensory system, the time and optionally, the location, of check-in foreach surgical implement is recorded. Following surgery, a comparison iscompleted of surgical implements checked-out and surgical implementschecked-in and a list is generated to identify which surgical implementsare missing, if any. An output device, such as a computer can be used todisplay the list. In addition, an alarm will sound if any surgicalimplements are checked-out but not checked back in from the sensor orthe output device. Alternatively, the sensor system can keep a runningcomparison of the surgical implements that have been checked-out and theones checked-in. In this manner the sensor system can be programmed toalert at particular times during the procedure in order to track thesurgical implements throughout the procedure.

The functions of the sensor system include, but are not limited to,sensing, tracking, marking, managing, monitoring, setting, controlling,checking, dating, timing, billing inventory control and comparing withprotocol. When the implements are placed on, in, or near the main orauxiliary sensor system, each is detected and assigned a unique andindividual identifier by the associated sensor system. The identifierused herein includes, but is not limited to, information regarding theproduct, numbers, strings of letters and numbers, strings of letters orother codes, or a frequency. The sensor system and the auxiliary sensorsystems as used herein include, but are not limited to, handhelddevices, perimeter systems, entry/exit systems, tables, trays, shelvesor stands.

In another embodiment, a backup system could be incorporated into thesurgical implements using a second integrated circuit, or tag, whichwould generate an error message when read by a sensor system if therewas a problem with a primary integrated circuit.

In another embodiment, the initial assigning of surgical implementidentifiers is performed when the surgical implements enter theoperating room.

FIG. 6 shows another embodiment of the present invention. A patient 299wearing an identification bracelet 300 is receiving fluids, medication,or blood 318, through tubing 315, intravenously 312. The identificationbracelet 300 contains a sensor system 310, which includes informationabout the patient 299, including allergies, medical orders, medicationorders, and the like. Each of the bags 318 and 320 include integratedcircuits 317 and 319 respectively, which may be placed directly on thebags 318 and 320 or incorporated into a label and then placed on eachbag 318 and 320. The integrated circuits 317 and 319 indicate what is inthe bags, either blood, medication, fluids, etc. Likewise, syringe 325contains medication and includes an integrated circuit 324, whichindicates what medication is in the syringe 325. If the contents of bag320 or syringe 325 are harmful, potentially harmful, or inappropriate inany way for patient 299, then when the integrated circuits 319 or 324come near the sensor system 310 located in the patient's identificationbracelet 300, an alarm/alert (not shown) will sound. In an alternativeembodiment, the sensor system can be located elsewhere in the patient'sroom. In addition, more than one integrated circuit can be located on oraround the patient. In another embodiment one or more integratedcircuits can be sensed by a sensor system and then the associatedinformation from each integrated circuit is compared to the other oralternatively to stored information. If the information does not match agiven set of parameters, an alert or alarm will sound.

In another embodiment of this invention, medical orders, such as formedical procedures, laboratory studies, or the like, are tagged with oneor more integrated circuits-integral or removable, and a sensor systemis located on or near the patient or in the patient record, card, chart,or hand held, or other computing platform. In another embodiment, thesensor system or sensor auxiliary device is located in the patientidentification bracelet, dog tag, or other suitable appliance.

The patient sensor system is preprogrammed with patient information,including, for example, allergies, current medications, medical problemlist, patient requests, consents, date of birth, name, insurance, nextof kin, contact information, and the like, and may be programmed withstatus updates or orders. If an inappropriately tagged blood product ordrug is brought in proximity to the patient, the sensor will trigger analert or alarm which can take many forms for easy identification.Similarly, if a disposable integrated circuit card, for example, a 2″ by3″ plastic card (i.e. credit card size) in which an integrated circuitwas embedded, for each procedure is generated, should an orderlycarrying this card approach the wrong patient for transport, an alertwill be generated. The integrated circuit can be, for example a flashmemory card or a smart card.

In another embodiment, a second integrated circuit can be located in thepatient identification bracelet or dog tag. If both the medical ordersand the patient identification bracelet contain integrated circuits,then the sensor system can monitor and track whether two integratedcircuits move too close together. For example if the wrong medicalorders were about to be placed in a patient's chart or the wrongmedicine was to be given to a patient. In this embodiment, the sensorsystem can indicate a conflict between two integrated circuits visuallyor audibly. In addition, an output device, such as a monitor, candisplay which devices are in conflict.

In yet another embodiment of this invention, pharmaceutical productshave one or more integrated circuits attached to the containers,bottles, bags, or labels which may be integral or removable forattachment to inventory lists, patient charts or intravenous (“IV”) orinjection apparatus as noted above. Remote sensors on hand held devices,located in cabinets where pharmaceuticals are stored, or situatedelsewhere, can quickly identify expired or misplaced or otherwiseinappropriate drugs. Effective tracking of inventory with appropriatesoftware is improved and appropriate ordering, billing and analysis ofother information are enhanced.

In another embodiment of the present invention, a medical label includesat least one integrated circuit. The medical label can also be just theintegrated chip. In addition, there can be more than one label on agiven medical product. The medical label can be used to label any typeof medical material or product, including pharmaceutical products andblood products, for example as shown in FIG. 6. The medical label canalso be placed on medical containers, such as boxes, boxes that containmedical products, crates that contain medical products, bottles,ampoules, bags, syringes, or the like. The integrated circuit within themedical label can include information about the origination of themedical product, verification information about the medical product, thedestination of the medical product, what the medical product is, whichpatient is to receive the medical product, indications,contra-indications, interactions, or similar medically or logisticallyrelevant information. The verification information can include data thatindicates the authenticity of the medical product. In addition, therecan be more than one medical label on a given medical product. Forexample, an integrated circuit as described (either in a label or as thelabel itself) can be used and at least one additional label in the formof a written description of the medical product can be also located onthe medical product.

In another embodiment where the medical label is used to label bloodproducts, the integrated circuit can include collection, processing,storage, distribution, usage, and patient delivery information.Collection, processing, storage information, usage and the like caninclude, information about the blood donor, the blood type, bloodrecipient, expiration date, unit number, antigens, antibodies,logistical information, delivery distribution, or combinations thereof.

In addition, the label can have certain physical and chemicalproperties. For example, the label can be temperature resistant, waterresistant, shock resistant, and flexible. The integrated circuit withinthe label can be hermetically sealed so that the environmentalconditions experienced by the label do not effect the integratedcircuit. For example, such environmental conditions can include theblood container containing the label being frozen and then thawed forstorage purposes. The blood products referred to in these embodimentscan include, but are not limited to, whole blood, platelets, packed redblood cells, and plasma.

EXAMPLE

A patient is prepped for a surgical procedure and brought into theoperating room. The operating room team comprising, for example, threeoperating room nurses, two doctors, and an anesthesiologist are alsopresent in the operating room. The operating room nurses are responsiblefor, among other things, tracking the sponges, scalpels, gauze, forceps,clamps, and other medical implements used during the surgery or surgicalprocedure. To this end, each surgical implement to be used in thissurgery includes an integrated circuit. As the nurses prepare for thesurgery, they place each of the surgical implements on or near a sensorsystem, which is located near to the operating table upon which thepatient lies. This sensor system registers each of the implements. Aseach of the implements is registered, the nurses watch the informationappear on a screen of the sensor system, (e.g., a display of a computer)for each of the implements: 1) what each implement is; 2) the time theimplement is placed on the sensor system; 3) the place where theimplement is being registered; and 4) a unique identifier assigned toeach implement is shown. Once all of the implements have beenregistered, the surgery can begin.

The doctors begin the surgery and each implement is used in turn. Aseach implement is used by the doctors, it is removed from the proximityof the sensor system. For example, when one of the nurses hands ascalpel to a doctor, the sensor system senses that the scalpel has been“checked-out” at a certain time. When the doctor has finished with thescalpel, a nurse can either put the scalpel back near the sensorplatform it was removed from or place the scalpel on or near anauxiliary sensor system (e.g., a sharps container). When, for example,the auxiliary sensor system senses the scalpel, the scalpel isregistered as “checked-in” and the location and time of check-in is alsonoted.

For each surgical implement, each of these steps can be performed.However, if at the end of the surgery, there are implements that havenot been checked-in, then the sensor system indicates which implementsare missing (e.g., not checked-in). In addition, prior to the doctorssuturing the patient, a nurse checks the sensor system (e.g., thedisplay of the computer mentioned earlier). In another embodiment, thesensor system can sound an alarm to remind the operating room team thatthere are implements missing.

Once the operating room team is aware that there are items missing andwhat items are in fact missing by looking at the information provided bythe sensor system (e.g., the display of the computer again) as to thedescription of the item, the check-out time, and the like, a doctor canuse an auxiliary sensor system in the form of a portable sensor systemto locate the implement. For example, if the implement is still withinthe patient, a portable sensor system comparable to sensor system 100but portable in nature is used to locate the missing implements.

CONCLUSION

Embodiments of devices, methods, systems to surgical implements andother medical products, including integrated circuits have beendescribed. In the foregoing description, for purposes of explanation,numerous specific details are set forth to provide a thoroughunderstanding of the present invention. It will be appreciated, however,by one skilled in the art that the present invention may be practicedwithout these specific details. In other instances, structures anddevices are shown in block diagram form. Furthermore, one skilled in theart can readily appreciate that the specific sequences in which methodsare presented and performed are illustrative and it is contemplated thatthe sequences can be varied and still remain within the spirit and scopeof the present invention.

FURTHER EMBODIMENTS

Other embodiments of the present invention are directed to electronicdevices and their use for tracking medical products such as medications,blood, and tissue to improve patient safety. The embodiments utilizeelectronic devices including but not limited to RF ID (radio frequencyidentification) devices which are attached to the medical products toassist in their safe production, distribution, and administration topatients. These devices may be programmed with information which ispertinent to the proper identification, routing, and administration ofthe medical products. The information may subsequently be read at anytime during the life cycle of the medical product. In a particularembodiment, the information is routed to computing systems where it maybe processed.

Medications:

One embodiment of the invention uses RE ID devices such as labels ortags for medications. The devices may be placed by any known process oncontainers, vials, ampules and the like. In one embodiment, commonlyused labeling information is visibly readable on each label or tag. Atthe point of manufacture, the labeling process involves applying one ormore labels having RE ID devices to the unit dose container. Ideally,one or more of these RF ID devices will be adhesive and removable forsubsequent attachment to IV bags, syringes, patient charts, smart cardsand the like. In one embodiment these devices are very thin, flexible,resistant to extremes of temperature, moisture, trauma and have a shelflife greater than four years. The devices may be readable and/orprintable and may, for example, contain certain data which may includebut not be limited to, drug type, name, formulation, interactions,dosages, expiration date, batch number, location of manufacturingfacility and contraindications. As the individual unit doses arepackaged, each packaged grouping also includes one or more labels havingRF ID devices attached to its larger subpackage with all the informationfound in each individual unit dose and with the number of individualunits contained in each package or subpackage. Hence, a large package orshipment of drug can have multiple RF ID devices arranged in such a waythat each subpackage is accounted for individually and sequentially withthe RF ID device of larger units accounting for the next level ofsmaller units. This pyramid design provides consistency and bettertracking ability as the units are easily referenced to larger master RFID units.

After the application of the devices to the pharmaceutical products,sensors note the distribution of the products through the facility andtheir exit as they are shipped to wholesalers or distributors, or tohealthcare facilities. Appropriate data is recorded and storedcentrally. As the products reach their destination they are data scannedand this information is again centrally processed. The products are thenrouted to the appropriate final locations, where they are kept in thepharmacy or sent to patient care areas. While there, essential data isrecorded locally and centrally. The use of scanners, which may beportable or fixed, within storage cabinets or other fixtures keeps trackof inventory and notes the presence of outdated drugs for easy disposal.Further, the presence of nonformulary products or concentrations as wellas other inappropriate medications can be made known to responsibleparties in a timely and effective manner. The presence of an LED, whichcould be programmed to emit light when expiration has occurred, or whichcould be induced to emit light when an external field is applied to anRF ID device on an expired drug package, would make identification eveneasier.

When an order for drug is received this too can be programmedelectronically such that the correct drug is automatically selected froma central distribution center or from a local drug access center. Here,the RF ID device could also assist in correct drug selection. When thecorrect package is chosen, relevant data is recorded for billing,inventory, and related referencing and for comparison with patient datato avoid allergic reactions, redundancy, and possible adverseinteractions.

At this point, one RF ID device may be taken from the unit package andplaced on the patient record, chart, or smart card. A second RF IDdevice which also has written drug data as to drug name, date ofadministration and concentration should be adhered to a syringe or IVbag. In a preferred embodiment, a smart card, chart, or ID band wouldhave an RF ID or other device containing relevant patient history,treatment, orders and other data and would be updated real-time or on afrequent basis. A sensor/processor unit compares the data from the IDdevices of the drug and the patient. This helps ensure thatcompatibility exists and the therapy is appropriate. In one embodiment,an enabling signal precedes therapy, and a failsafe signal is generatedto alert appropriate parties that a level of patient safety is breached.The sensor processor unit can be integral with the patient RF ID tag,for example on the patient ID bracelet, with the ability to transmit toa central computer or processor, or it may be physically separate as astand alone device or one receiving and relaying data to a centrallocation. The sensor/processor device may be linked to central data andcomputer systems by wireless or other commercially available means.

Blood/Tissue Products:

Other embodiments of the invention disclose the use of RF ID devices inprocessing and administering blood products and the transplantation oftissue products to human patients. At the point of collection, one ormore RF ID devices are appended to the collected blood. Relevant data isencoded on them as to collection time and date, typing or otheressential data, method of viral inactivation and the like.Alternatively, a radio frequency bar code may be used. If the blood isfractionated, one or more RF ID devices are attached to each derivedunit of product. This is done in such a way that all the data containedin the first RF ID application are contained in all subsequently writtenRF ID labels with the relevant new data for the derived products encodedor written subsequently. Hence, products can be tracked easily back tothe original donor and source. The RF ID devices are able to withstandthe processes required for the preparation of safe blood products andtheir derivatives. Hence, the RF ID devices are water resistant,resistant to physical stresses and the extreme cold used in the storageof blood products. They generally have long shelf lives, but this isunnecessary for packed red blood cells. Encapsulation may be used to addto their durability, and the RF ID devices can be thin, flexible,adherent and easily removable and reattachable. One of the series ofapplied RF ID devices serves as the master RF ID and is undetacheableexcept through removing the RF ID device from the adherent portionallowing its inclusion to a master database after use. A central sensoris able to distinguish among the units stored in a single location andindividually track their data. Hence, real-time inventory is achieved.

When units and products are distributed, their routes and destinationsare noted and recorded. On arrival to a hospital or other healthcarefacility, a sensor confirms their arrival and records the data. This canbe relayed back to the place of origin for confirmation. Once again, asensor distinguishes among the many different units stored in onelocation and that information is stored centrally. If other typing isdone, that data is added to the RF ID labels on the appropriate units.When the hospital types or screens a patient for the receipt of theproduct, that information is centrally stored and the chosen units havetheir RF ID tags updated and further encoded with that additionalpatient data.

Alternatively, a second series of RF ID tags can be generated andapplied to the appropriate units. Electronic or other mechanical orfunctional linkage can be used. When a unit of product is ordered, theinformation is recorded centrally. When the unit of the product arrivesat its destination, it is again sensed and appropriate data isdisplayed. When the unit is taken for patient administration, this isnoted by the local sensor and relayed centrally. When the unit is takento the patient, another patient specific RF ID, or other device, on apatient ID bracelet, smart card or chart or nearby allows for comparisonbetween the patient data and the product data. The sensor/processor canbe integral to the patient specific RF ID device or separate in a localor central locale as noted above. Before administration, positiveenablement can be achieved. A failsafe mechanism signals an alarm if anyincompatibility is present, providing passive security. This processfacilitates processing, distribution, record keeping, inventory,billing, and improves patient safety and decreases product waste.

FIG. 7 shows an infrastructure 410 in which the principles describedherein can be useful. Generally, it will be appreciated that throughoutthe life cycle of a medical product, a number of entities/facilities maybe involved. For example, a source facility 412 such as a drugmanufacturer or blood bank may transport the medical product to adistributor facility 414, where the distributor facility 414 distributesthe medical product to one or more health care facilities 416. As willbe discussed in greater detail below, each facility maintains a centraldatabase 418 of source data and/or patient, where each database 418 maybe accessed by the other facilities in the infrastructure 410 vianetwork 420.

By way of example, it can be seen that an assembly 422 of medicalproducts includes a first unit 424 and a second unit 426. The first unit424 of the medical product includes a first unit RF ID 428, which may beincorporated into a label as discussed above. The first unit RF ID 428uniquely identifies the medical product and the first unit 424.Similarly, the second unit 426 of the medical product has a second unitRF ID device 430 where the second unit RF ID device 430 uniquelyidentifies the medical product and the second unit 426. It can furtherbe seen that packaging 432 such as shrink wrapping, box or crate,combines the first unit 424 and the second unit 426 into a group.Furthermore, the packaging 432 has a group RF ID device 434, where thegroup RF ID device 434 uniquely identifies the medical product, thefirst unit 424 and the second unit 426. It will be appreciated that themedical product can include pharmaceutical products, blood products,tissue products, or any combination thereof. It should also be notedthat the group identified by the group RF ID device 434 typicallyincludes many more units than the two illustrated.

It will further be appreciated that a first supplemental RF ID device436 may be removably attached to the first unit 424, where the firstsupplemental RF ID device 436 also uniquely identifies the first unit424. This allows the first supplemental RF ID device 436 to besubsequently reattached to other containers such as vials, syringes,etc. if the first unit 424 is fractionated. Similarly, a secondsupplemental RF ID device 438 may be removably attached to the secondunit 426. The second supplemental RF ID device 438 uniquely identifiesthe second unit 426. The supplemental RF ID devices may be applied atthe source facility 412, the distributor facility 414 or anywhere elsein the distribution chain of the medical product.

As already discussed, the RF ID devices may include source data and unitnumber data. In the case of pharmaceutical products, data may includebut is not limited to drug-type data, drug-name data, formulation data,interaction data, dosage data, expiration data; batch number data,indication data, cartron indication data, or combinations thereof. Inthe case of blood products, data may include, but is not limited toblood donor data, blood type data, expiration data, antigen data,antibody data, or combinations thereof.

It can further be seen that facilities such as health care facility 416a may include one more sensing systems 440 in communication with the RFID devices 428, 430, 434, 436, 438 and a central processing unit (CPU)442. While communication is illustrated as being implemented via a busnetwork 444, it will be appreciated that any appropriate local areanetworking (LAN), wireless networking, or other architecture may beused. It can be seen that the CPU 442 is coupled to the central database418 a and associates the received data in accordance with any number ofcommercially available database approaches.

Turning now to FIG. 8, health care facility 416 a is shown in greaterdetail. Specifically, it can be seen that the assembly of medicalproducts enters the health care facility 416 a at receiving area 446.The group RF ID device 434 is scanned using sensor 448 a in order to logthe uniquely identified first unit 424 and second unit 426 in as beingreceived. This enables unit data and source data to be associated withany patient data/location data that may be entered into computingterminal 450 a. This information is transmitted to the CPU 442 forstorage in the central database 418 a.

It can be seen that as the units 424, 426 move throughout the healthcare facility 416 a, the overall system enables tracking of suchmovement as well as updating of any relevant patient data. For example,in the illustrated example, the first unit 424 is sent to a treatmentarea 452 and is placed in a pharmaceutical cabinet 454 for temporarystorage. Before placement in the cabinet 454, the first unit RF IDdevice 428 can be scanned by sensor 448 b, where the treatment arealocation is associated with the first unit 424. Additionally, the firstunit RF ID device 428 may communicate with a sensor 448 e mounted withinthe cabinet 454. It can further be seen that a patient chart 456 has apatient data RF ID device 458. In the illustrated example, the firstsupplemental RF ID device 436 may be attached to the patient chart 456and any conflicts can be detected and reported as discussed above.

It can further be seen that second unit 426 is sent to a pharmacy 460for storage until an order is placed for the particular medical product.It can be seen that if the second unit 426 is fragmented to asupplemented container 462, the second supplemental RF ID device 438 canbe attached to the supplemental container 462 in order to document thefragmentation. Thus, when the supplemental container 462 is sent totreatment area 464, sensor 448 d and terminal 450 d can initiate anupdate of the central database 418 a.

Turning now to FIG. 9, a method 467 of tracking medical products isshown. Processing block 468 provides for receiving the shipment, whichcontains the assembly of medical products. A group of medical productsis associated with a group location at block 470 based on a group RF IDdevice: signal. As already discussed, the group includes a first unitand a second unit. Block 472 provides associating the first unit with afirst remote location based on first unit RF ID signal. The second unitis associated with a second remote location at block 474 based on asecond unit RF ID device signal. The signals uniquely identify the unitsand the group.

EXAMPLE SCENARIOS:

The following scenarios illustrate by way of example certain of theprinciples of the embodiments of the present invention:

Scenario #1:

A widely used medication is received by a hospital. A tracking device inaccordance with the present invention is affixed to each vial of themedication, and the vials are distributed to various locations withinthe hospital. Prior to distribution, tracking information such asproduct type, name, formulation, interactions dosages, expiration date,batch number, manufacturing facility, handling and storage information,and distribution locations are entered into a central computer. At alater date, it is discovered that the expiration date of the medicationis in error, and that it will shortly expire. Using the informationstored in the central computer, the locations of the medication arerapidly determined, so that removal and disposal can be achieved.Alternatively, a sensor in a storage cabinet periodically scans allmedications and directly identifies the presence and location of theexpired drug. It is also possible to have a pre-programmed timer, clockor a chip or other circuit such that an individual RF ID deviceindependently emits a signal when a certain date is reached which may benoted with a passive or active sensor array or by a characteristicsound, light or electrochemical color change of part or all of theprinted label or package. A battery source set to expire at or near theexpiration date of the pharmaceutical may also be used, wherein when thebattery source expires an alert is issued.

Scenario #2:

A patient is to undergo emergency surgery immediately. Information,including that relating to the patient's allergies or other drugreactions is written on the patient's RF ID bracelet in accordance withembodiments of the present invention. In the operating room just priorto surgery, the anesthetics to be used during the operation areautomatically scanned and this information was processed with theinformation on the ID bracelet. It is discovered that one anestheticagent would produce a severe reaction in the patient. A safe substituteanesthetic is suggested by the system and was subsequently used duringthe procedure with good result.

Scenario #3:

A patient arrives at the ER complaining of vomiting blood. A type andcross is sent immediately and information is encoded and written on thecentral computer and on the RF ID label directly and immediately placedon the ER patient's sample tube at the point of blood sampling. Thistube arrives at the hospital blood bank where it is scanned to avoidclerical and other errors involving patient data. The central computerhas already used the patient data to access previous data from priorhospital or clinic visits, and may use the internet or other knownmodality to access confidential and necessary health information fromany hospital, physician, insurer or other reliable source. In the bloodbank, blood typing data is obtained rapidly and RF ID labels areappropriately written. The results are automatically compared with thoseobtained previously during prior admissions or with data from the cityblood bank or American Red Cross. Differences, such as new antibodiesare noted and the records upgraded throughout. Any obvious clerical orother errors are also ruled out very effectively by this process ofcomparison. the patient deteriorates and undergoes emergency surgery.

Suppose blood is ordered and sent to the operating room (OR). Whilebringing the blood to the OR, an extra bag that was in storage foranother patient is taken unwittingly. When placed in the dedicatedpatient storage container or area, automatic scanning indicates thepresence of this unit of blood. If this should fail a scanner integralto or near the patient ID bracelet would note the discrepancy and issuea warning such that the wrong unit not be given. When each unit isgiven, the used bags are placed in a waste area, where the RF ID tagsare again scanned. This information is sent to the blood bank forclosure of the loop. This prevents units from becoming lost or otherwisewasted in a busy OR. This also allows for real time tracking of blooduse in the OR by the blood bank, which can then better keep up withdemands and improve logistics. This is very important if a nonhospitalor city blood center's resources should become required on short notice.Further, the blood bank would avoid unnecessary processing of unneededblood and blood products which would need to be used quickly or wastedonce prepared.

In the foregoing detailed description, devices, systems and methods inaccordance with embodiments of the present invention have been describedwith reference to specific exemplary embodiments. Accordingly, thepresent specification and figures are to be regarded as illustrativerather than restrictive.

1. An assembly of medical products, the assembly comprising: a firstunit of a medical product including an integral first unit radiofrequency identification (RF ID) device, the first unit RF ID deviceuniquely identifying the medical product and the first unit; a secondunit of the medical product having an integral second unit RF ID device,the second unit RF ID device uniquely identifying the medical productand the second unit; a first supplemental RF ID device removablyattached to the first unit, the first supplemental RF ID device uniquelyidentifying the first unit; and a second supplemental RF ID deviceremovably attached to the second unit, the second supplemental RF IDdevice uniquely identifying the second unit.
 2. The assembly of claim 1,wherein the first and second supplemental RF ID devices are configuredto be reattached to another item.
 3. The assembly of claim 2, whereinthe other item is at least one of a medical container, a patient chart,an IV or injection apparatus, and a patient bracelet.
 4. An assembly ofmedical products, the assembly comprising: a first unit of a medicalproduct including a first unit radio frequency identification (RE ID)device, the first unit RF ID device uniquely identifying the medicalproduct and the first unit; a second unit of the medical product havinga second unit RF ID device, the second unit RF ID device uniquelyidentifying the medical product and the second unit; a firstsupplemental RF ID device removably attached to the first unit, thefirst supplemental RF ID device uniquely identifying the first unit andconfigured to be reattached to another medical product or unit; and asecond supplemental RF ID device removably attached to the second unit,the second supplemental RF ID device uniquely identifying the secondunit and configured to be reattached to another item.
 5. The assembly ofmedical products of claim 4, wherein the other item includes at leastone of a medical container, a patient chart, an IV or injectionapparatus, and a patient bracelet.
 6. The assembly of medical productsof claim 4, wherein the first unit RF ID device is integral with thefirst unit and the second unit RF ID device is integral with the secondunit.
 7. A tagged medical product, comprising: an integral unit radiofrequency identification (RF ID) device, the integral unit RF ID deviceuniquely identifying the medical product; a removable unit radiofrequency identification (RF ID) device, the removable unit RE ID deviceuniquely identifying the medical product and configured to bereattachable to another item.
 8. The tagged medical product of claim 7,wherein the other item is at least one of a medical container, a patientchart, an IV or injection apparatus, and a patient bracelet.